Ten Tips for A IRB Administrator Cynthia Lutzmann Perfect IRB - - PDF document

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Ten Tips for A Perfect IRB Application!

Modified by: Lauren Maziarz PhD, RN Spring 2016

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Lourdes University IRB

IRB Administrator Cynthia Lutzmann Chairperson Lauren Maziarz, Ph.D., R.N., Scientist Members Robert Campbell, M.A., Non-Scientist Rachel Duff Anderson, M.S.W., Non-Scientist Barbara Grover DNP, CRNA Scientist Christine Knaggs PhD Non- Scientist Patrice McClellan, Ed.D., Non-Scientist Terry Strode, MOL, Non-Scientist Community Member Sharla Cook RDLD, IBCLC Ex officio members

• Sr. Shannon Schrein, Ph.D., Dean of the Graduate School, Non-Scientist

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Objectives

• Lists the functions of the IRB
• Review the submission process
• Discuss appropriate information needed for various

sections of the IRB application

• State the indications for the use of the exempt versus

expedited IRB application

• Recall the IRB application process
• Locate IRB resources on the University website

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Tip #1 Complete CITI training

• Why CITI training?
• CITI Training
• Stage 1 : good for 3 years
• Stage 2 and 3: good for 3 years
• Keep copy of training certificate
• Advisors and students must be CITI trained

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TIP #2 Involve Advisor in the IRB Process

• Advisor responsibilities
• Review signature page
• Electronic signatures are needed

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Tip #3 Be familiar with the IRB website

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• How to get there
• http://www.lourdes.edu/academics/institutional-review-board/ or
• www.lourdes.edu click on academics and click on Institutional

Review Board

• Locate Forms
• Getting Started – Questions to Ask:
• What is research?
• Are human subjects involved?
• Is the research exempt versus expedited?

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OK- SO IT IS RESEARCH

Obtain permission from the site where data collection will happen Review agency permission Use of Lourdes’ permission form

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Tip #4 Recall the Belmont Report

• Respect for Persons
• Individual autonomy
• Protection of individuals with reduced autonomy
• Beneficence
• Maximize benefits and minimize harms
• Justice
• Equitable distribution of research costs and benefits

Three Basic Ethical Principles:

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Tip #5 Look at Decision Trees to Determine Exempt or Expedited

• Review – Exempt, Expedited, or Full Board Review
• Decision - Exempt versus expedited?
• Go to “federal regulations”
• Click on decision charts
• Go to “IRB definitions” – Read about exempt versus expedited
• Note #6 & 7 under “expedited” – MAJORITY of Lourdes University

Research falls under these two categories

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Tip #6 Complete All Sections and Summarize Information for A General Audience

• Review the check list
• Summary of the proposed study in professional voice but use

terms that are understood by all disciplines

• Significance of the problem- Gap/problem noted in the

literature – cite key references

• How do you want to proceed with the study?
• What do you want to find out as a result of the study?
• Summary denotes that all words have meaning
• Be concise – unnecessary to fill the entire space

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Expedited - Continued

• Research questions – in question form
• Research method – what research approach are you using to
• btain the data ?
• Setting – where is the research taking place (i.e. where is the

data collection occurring)

• Need permissions, IRB approval from other institutions in order

to be in that setting

• Participants
• Who are they?
• Why are they chosen?

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Expedited - Continued

• Recruitment of participants
• How - check the type of communication
• Process – state where and who the communication comes from,
• Order of events
• Detailed description of informed consent process
• Written? Implied? Signature waived? When to waive?
• Email script to serve as “ informed” portion of informed consent*
• Participants must be informed regardless of method
• Provide Rationale for using a vulnerable group
• Participants – number, type, ability to give consent
• Smaller numbers of participants may be associated with more

risk to identity * See sample email script

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Expedited - Continued

• Data and Consent Collection
• Methods
• Instruments/tools for collection
• Need evidence of permission to use another’s tool
• Or state that the “tool was created by the researcher”
• Identifiers versus non identified information
• Privacy protection and data storage- use of password

protected websites, password protected computers

• Survey Gizmo and Survey Monkey

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Expedited - Continued

• Risk
• Choose risk criteria
• Potential for deceit, coercion, peer pressure
• Compensation
• Benefits to participants if any
• Contributions to general knowledge in the discipline
• Choose risk category
• If greater than minimal risk – full IRB review is required
• 3rd parties – consider presentations, manuscripts, etc. or if

participant is harmed then disclosure is necessary but must be stated in the consent form

• Attach all documents – consent forms, surveys, agency

permission forms, CITI training certificate

• Email to irb@lourdes.edu

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Tip #7 Summarize and complete Exempt applications.

• Final determination of the application status rests with the IRB
• Complete exempt category and screening questions – return with

application

• Similar to Expedited in that you should be brief but succinct
• Include all requested information – use lay terms
• Attach all documents – consent forms, surveys, agency permission

forms, CITI training certificate

• Email to irb@lourdes.edu

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# 8 Always Proofread

• This means more than spell check

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Tip #9 Attach Appropriate Forms

• E copies
• IRB Application
• Recruitment Flyer/s
• Survey/s
• Agency permission
• Waiver of consent signature if appropriate
• Consent form
• IRB approval letters from other institutions**

** Agreement with ProMedica

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Please Note >>>>>>>>>>

Under no circumstances may research begin until the IRB approval letter is received.

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Tip # 9.5 Inform IRB for Changes in Protocol/Procedure

• Approval is good for one year
• Approval is for the research protocol as outlined in the

applications

• Changes to the protocol can be made by using an AMENDMENT

Form found under Forms on IRB webpage

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Tip #10 Remember to complete the closure form

• Necessary to close the project down –for research protocols

that required expedited and full board reviews.

• Project is finished
• Final of report of adverse events
• Summary of findings
• Alternative to a closing a research protocol is a Continuing

Review: Another form of course!

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Service with A Smile Understand the IRB Administrator Process

• Procedure
• Review process
• Exempt
• Expedited
• Full
• # of reviewers
• Timeline – 7 to 10 Days for review (each cycle)
• Forms
• Notifications/communications- use Lourdes’ email system
• Advisor is copied on all emails from IRB

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Questions!

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